Biopharma Group Invests in Two New Cat D Cleanrooms to Upscale its CDMO Capabilities

Biopharma Group – a leading provider of specialist freeze-drying products and services – has announced the launch of two new Category D cleanrooms at its headquarters in Winchester, UK. This investment demonstrates Biopharma Group’s commitment to providing flexible, efficient and high-quality CDMO (Contract Development and Manufacturing Organisation) solutions for its customers.

Category D cleanrooms are carefully controlled environments with low levels of pollutants, such as dust, airborne microbes and other contaminants. By adding these cleanrooms to its facilities, Biopharma Group is scaling-up its manufacturing capacity, while continuing to ensure that its customers’ products are developed to the most rigorous standards of safety and quality.

Biopharma Group has invested in these assets to answer the diagnostics industry’s increasing demand for robust and reliable point of care (PoC) solutions. The two new cleanrooms enable its expert scientists to further meet the specific needs of its PoC customers – including the requirement for stringent cleanliness and environmental stability standards throughout the production process.

As a result of expanding capacity, the lab team can manufacture a wider range of products within its new cleanrooms. These include non-sterile pharmaceuticals and non-sterile diagnostic tests – such as lateral flow assays and PoC diagnostic devices. 

Designed to the latest specifications, the cleanrooms are equipped with advanced filtration systems, including HEPA filters, which significantly reduce airborne particles. They also meet the rigorous standards set by regulatory bodies – such as the International Organisation for Standardisation (ISO) – providing assurance that all products developed within the rooms will be compliant.

Additionally, the cleanrooms allow for users to have control over their environmental conditions, such as temperature, humidity and pressure. This level of control is essential for maintaining the quality and stability of products throughout the development and manufacturing process. The rooms also feature advanced freeze dryers, laminar airflow systems, and glove boxes – otherwise known as isolators. 

Chelsea Gemmell, Head of Production at Biopharma Group said:

"The opening of two new Category D laboratories marks a significant milestone in our production capabilities. These facilities will enable us to enhance our manufacturing processes, ensuring the highest standards of quality and safety for the products we produce. This investment underscores our commitment to our customers, and we look forward to the positive impact these cleanrooms will have."

To learn more about our expanded CDMO services and how our Cat D cleanrooms can benefit you, please get in touch to discuss your requirements with one of our specialists today.